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Safety, Tolerability, and Efficacy of AXA1125 in NASH With Fibrosis

NCT04880187 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2022-09-08

No results posted yet for this study

Summary

This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.

Conditions

  • Non Alcoholic Steatohepatitis (NASH)

Interventions

DRUG

AXA1125

AXA1125 administered BID with or without food

DRUG

Placebo

Matching Placebo administered BID with or without food

Sponsors & Collaborators

  • Axcella Health, Inc

    lead INDUSTRY

Principal Investigators

  • Stephen Harrison, MD · Pinnacle Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-07
Primary Completion
2023-09-30
Completion
2023-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Poland
  • Puerto Rico
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880187 on ClinicalTrials.gov